Cai Xun, Xue Peng, Song Wei-feng, Hu Jiong, Gu Hong-li, Yang Hai-yan, Wang Li-wei
Department of Oncology, Shanghai First People's Hospital, Shanghai Jiaotong University, Shanghai 200080, China.
Zhonghua Zhong Liu Za Zhi. 2012 Jan;34(1):39-43.
To investigate the relationship between serum concentration of fluorouracil and therapeutic efficacy as well as adverse reactions in patients with unresectable locally advanced or measurable metastatic colorectal cancer, and to analyze its role in further improving therapeutic efficacy and reducing adverse reactions of fluorouracil-based chemotherapy.
Eighty-six patients were randomly assigned into three groups according to the average plasma concentration of fluorouracil after three cycles of chemotherapy with the initial regimen of two weeks FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil) or FOLFIRI (irinotecan + leucovorin + fluorouracil): group 1 (plasma concentration of fluorouracil < 25 ng/ml), group 2 (25 - 35 ng/ml) and group 3 (> 35 ng/ml). The blood samples were taken at 12 h after continuous infusion of fluorouracil in each cycle and the plasma concentration of fluorouracil was detected by high performance liquid chromatography (HPLC) (about 5 am ± 1 h). The relationship between the drug plasma concentration, therapeutic efficacy and adverse reactions in different fluorouracil plasma concentration arms was analyzed retrospectively.
The average plasma concentrations of fluorouracil of the three groups were (23.48 ± 1.95) ng/ml, (31.47 ± 2.33) ng/ml and (39.89 ± 3.87) ng/ml, respectively (P < 0.01). As for therapeutic efficacy, the median OS of the groups 2 and 3 were 18.0 and 17.5 months, significantly higher than that in the group 1 (13.0 months, P < 0.01). The PFS were 4.5, 7.5 and 8.0 months, respectively (P < 0.01). In terms of adverse reactions, the incidences of bone marrow suppression, mucositis and diarrhea in the group 3 were significantly higher than that in the first two groups (P = 0.02, P = 0.04 and P = 0.02).
The patients with local advanced and metastatic colorectal cancer, receiving fluorouracil-based chemotherapy, and with an average plasma concentration of fluorouracil between 25 - 35 mg/L have a better prognosis, and lower incidence of adverse reactions such as bone marrow suppression, mucositis and diarrhea.
探讨不可切除的局部晚期或可测量的转移性结直肠癌患者血清氟尿嘧啶浓度与治疗疗效及不良反应之间的关系，并分析其在进一步提高基于氟尿嘧啶化疗的疗效及降低不良反应方面的作用。
86例患者在接受初始为期两周的FOLFOX-4（奥沙利铂+亚叶酸钙+氟尿嘧啶）或FOLFIRI（伊立替康+亚叶酸钙+氟尿嘧啶）化疗方案三个周期后，根据氟尿嘧啶平均血浆浓度随机分为三组：第1组（氟尿嘧啶血浆浓度<25 ng/ml）、第2组（25 - 35 ng/ml）和第3组（>35 ng/ml）。在每个周期连续输注氟尿嘧啶12小时后采集血样，采用高效液相色谱法（HPLC）（约上午5点±1小时）检测氟尿嘧啶血浆浓度。回顾性分析不同氟尿嘧啶血浆浓度组中药物血浆浓度、治疗疗效和不良反应之间的关系。
三组氟尿嘧啶平均血浆浓度分别为（23.48±1.95）ng/ml、（31.47±2.33）ng/ml和（39.89±3.87）ng/ml（P<0.01）。在治疗疗效方面，第2组和第3组的中位总生存期分别为18.0个月和17.5个月，显著高于第1组（13.0个月，P<0.01）。无进展生存期分别为4.5、7.5和8.0个月（P<0.01）。在不良反应方面，第3组骨髓抑制、黏膜炎和腹泻的发生率显著高于前两组（P = 0.02、P = 0.04和P = 0.02）。
接受基于氟尿嘧啶化疗的局部晚期和转移性结直肠癌患者，氟尿嘧啶平均血浆浓度在25 - 35 mg/L之间时预后较好，骨髓抑制、黏膜炎和腹泻等不良反应发生率较低。
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